Charger™ H74939206061010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804291), received between Nov 25, 2019 and Nov 19, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 6.0 X 200 X 150 STERLING BALLOON CATHETER WAS ADVANCED BUT ALSO RUPTURED AFTER BEING INFLATED AT NOMINAL PRESSURE. THE DEVICE WAS ALSO REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871311 ↗
• MalfunctionOct 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SAFELY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10646338 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND EMBOLIZATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR FEMORAL ARTERY. A 6.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AND LEFT AN EMBOLUS BEHIND. NO KNOWN FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT CONTRAST WAS OBSERVED AFTER THE BALLOON RUPTURED AND NO PART OF THE BALLOON WAS LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: Embolism

  MAUDE report 9490436 ↗
• MalfunctionDec 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST AT NOMINAL PRESSURE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415837 ↗
• MalfunctionNov 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 6.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370621 ↗